Biotech Buzz, October 2013


October, 2013

 Time to Renew Your Biotech Membership and Select Your Voting Status……………………………………… 2

Sign up for Biotech’s “Lyris List” to Receive Committee Communications and to Send Emails to Other Members           3

Join Biotech’s LinkedIn Group……………………………………………………………………………………………………….. 3

Biotech Wins First AIPLA Committee of the Year Award!………………………………………………………………. 3

Changing of the Guard…………………………………………………………………………………………………………………… 3

Biotech Work Plan for 2013-14 Submitted to AIPLA Leadership…………………………………………………… 4

Case Law Review……………………………………………………………………………………………………………………………. 4

Bayer CropScience AG v. Dow AgroSciences LLC., Case No. 2013-1002 (Fed. Cir. Sept. 3, 2013).. 4

Aria Diagnostics, Inc. v. Sequenom, Inc., Case No. 2012-1531 (Fed. Cir. 2013)………………………….. 4


Time to Renew Your Biotech Membership and Select Your Voting Status

Your present voting status is NON-VOTING.  If you want to vote on Biotech Committee resolutions, you must go into your AIPLA Profile and elect “VOTING” for the Biotech Committee by about December 18, 2013

Instructions for renewing your membership on Biotech and selecting a voting status.



In order to be able to vote on things like resolutions, recommendations, amicus positions, and communications from AIPLA about Biotech IP issues to Congress or to the USPTO, you must be a Voting Member of the Biotech Committee.  Over the last few years, we have conducted 1-2 votes annually.  You can only vote if you are a “Voting Member.”

About half of the Biotech Committee’s ~900 members had “Voting” status at some time in the past.  The other half had the status of “Information Only.”  Despite having so many members “with the vote,” when it came to actual voting, our committee, like most others, never received enough votes on any matter to meet quorum requirements.  A quorum is 50% of members with votes.  A vote that does not meet these standards can still be submitted to the Board, but the Board would be justified in giving little weight to it.

Over the last few years, we have conducted 1-2 votes annually.  You can only vote if you are a “Voting Member.”

AIPLA recently implemented new rules relating to voting status:

  1. You must to re-establish committee membership and Voting vs. Non-Voting status each year.
  2. You may be a “Non-Voting” member of as many committees as you like.
  3. You may elect to be a Voting member of up to 3 substantive committees.  Biotech is a substantive committee.
  4. You may be a Voting member of up to 2 other committees.
  5. Each year, during the Annual Meeting, your voting status on all committees will be reset to “Non-Voting.”
  6. Each year, you will have 60 days from the Annual Meeting to go onto your AIPLA profile and select your membership and voting status on the Biotech Committee. 
  7. If you do not select Voting status on the Biotech Committee by the deadline, you will not be able to vote until October 2014. 

So, if you want to be able to vote on anything that the Biotech Committee puts up for a vote between now and next October, please select “Voting” in your profile before about December 18, 2013.


Sign up for Biotech’s “Lyris List” to Receive Committee Communications and to Send Emails to Other Members

The Lyris List is the Biotech Committee’s list of the email addresses of those members who have opted to be included on the committee’s email communications.  Each Biotech member who has joins the Lyris List may use the list to send communications to all other list members.

If you join the Lyris List, you will get all of the committee’s email communications.  Over the last year, we had ~18 Lyris List communications.  The Biotech Buzz, for example, is sent via the Lyris List.  Notices about votes are sent via the Lyris List.  Surveys are sent via the Lyris List.  We expect that the Lyris List will be used more in the future, but not to the point of being annoying.

If you do not join the Lyris List, you will not get any of the committee’s email communications. 

Instructions for joining Biotech’s Lyris List.


Join Biotech’s LinkedIn Group

The Biotech Committee has a LinkedIn group that also helps members communicate with each other. 

Instructions for joining Biotech’s LinkedIn group.


Biotech Wins First AIPLA Committee of the Year Award!

AIPLA instituted a new award this year – Committee of the Year – and the Biotech Committee won the award at the Annual Meeting last week!  A picture of the award and acknowledgements of contributions this last year are in a slide show presented during Biotech’s business meeting last week in Washington.  Many thanks to the many committee members who worked on projects during the last year and delivered on commitments to get things done. 


Changing of the Guard

By Jim Kelley, Out-Going Chair

As of November 1, I will no longer be Chair of the Biotech Committee, but I intend to remain involved as Biotech’s liaison with the Corporate Practice Committee, as a partner with in-coming Chair Suzannah Sundby in liaising with a number of other IP associations on biotech IP issues, and as a strong supporter of our in-coming leadership team.  The new team is excellent.  They are going to improve our Committee.  I urge you to get involved, stay involved. 

Some have asked me why I approached things the way I did, and of course there are many reasons, but primarily, IT WAS FUN!  I got to work on important, interesting issues with smart, dedicated people.  I really enjoyed the opportunity to serve AIPLA and the Biotech Committee and to get to know and to work with so many people.  As a result, I have many people to thank for their contributions, but I fear if I tried to name everyone I will forget someone.  If you look back at all the Biotech Buzz issues, you will see their names.  Suffice to say that ~100 people on our ~900-member committee have done something “more than simply pay dues” over the last few years.  That is actually incredible.  Thank you, each and all.  Keep it up.  Get involved, stay involved.


Biotech Work Plan for 2013-14 Submitted to AIPLA Leadership

In-coming committee leaders, Suzannah Sundby and Tim Meigs, prepared the committee’s 2013-2014 Work Plan, which includes the following items:

  1. Expand Educational Services – for members and the public.
  2. Broaden Breadth of Biotech Issues – including new subcommittees Industrial Biotech, Biotech Litigation, and PTAB Actions, and refreshing the objectives of other subcommittees
  3. Strengthen Relationships with Sister Committees/Organizations and the USPTO – including especially the Chemical Practice, Food and Drug, Education, and Corporate Practice Committees within AIPLA and with ABA, BIO, CIPA, EPI, IPO, IPTA, JPAA, and LES outside of AIPLA.
  4. Increase Community Involvement – including encouraging and organizing informal membership interactions for social purposes, and forming new subcommittees, such as Corporate Biotech Practice, Academia and Research Institutions, and regional subcommittees.

Please volunteer to work on something that interests you by contacting any of the in-coming leaders:


Case Law Review


Link to Case Law Review

Bayer CropScience AG v. Dow AgroSciences LLC., Case No. 2013-1002 (Fed. Cir. Sept. 3, 2013)

Reviewed by Alice O. Martin, Lynn C. Tyler, and Michael Brunelle of Barnes & Thornburg, Indianapolis, IN.

Aria Diagnostics, Inc. v. Sequenom, Inc., Case No. 2012-1531 (Fed. Cir. 2013)

Reviewed by Alice O. Martin, Lynn C. Tyler, and Michael Brunelle of Barnes & Thornburg, Indianapolis, IN.


BIOTECH BUZZ September, 2013


September, 2013


Committee Meetings……………………………………………………………………………………………………………………… 2

Introduction of New Committee Leaders and Plans, 25 October, Washington DC……………………. 2

Biotech Social, Stone’s Throw Restaurant, Washington DC, Thursday, 24 October, 6:00-7:00…. 2

Programs……………………………………………………………………………………………………………………………………….. 2

CLE: Overcoming Barriers to New Technologies, 25 October, Washington DC…………………………. 2

USPTO Relations Subcommittee…………………………………………………………………………………………………….. 3

Report from BCP Customer Partnership Meeting – 9 September 2013……………………………………. 3

Committee Annual Survey……………………………………………………………………………………………………………… 4


Committee Meetings

Introduction of New Committee Leaders and Plans, 25 October, Washington DC

Suzannah K. Sundby of Smith, Gambrell & Russell, LLP will become chair and Tim Meigs of Becton Dickinson will become vice chair at the annual meeting.  Please join them for a short business meeting at 3:30-3:40 just prior to the CLE session described below.  They will present a brief description of their plans for the next year.

Biotech Social, Stone’s Throw Restaurant, Washington DC, Thursday, 24 October, 6:00-7:00.

While you’re at the annual meeting, please join us for drinks and socializing with panelists and committee members at the Stone’s Throw restaurant on the first floor of the Wardman Park Marriott hotel on Thursday, 24 October, 6:00-7:00.  The time was selected to give you many options for managing your business, the meeting, and other social engagements.  As usual, it’s a cash bar.



CLE: Overcoming Barriers to New Technologies, 25 October, Washington DC

The Biotechnology Committee and the Food and Drug Committee will sponsor a joint educational session (120 minutes of CLE) that will consider the history of the public’s love-hate relationships with new technologies and will include discussion of causes of these conflicting attitudes and their effects on progress. The global status of intellectual property protection in patent offices, regulatory agencies, and the courts will be analyzed to elucidate the issues involved. Solutions for meeting these concerns and attitudes and proposals for developing programs of public education and fostering policies for protecting intellectual property that are beneficial to the public will be presented.

Alice Martin and Bruce Vrana, co-chairs of our Plant Biotechnology subcommittee, will moderate the all-star panel that they put together:

History of Genetic Technologies: Acceptance and Hurdles to Protection Dr. Ananda Chakrabarty, Distinguished University Professor, University of Illinois at Chicago

Addressing Public Fears of New Technologies Professor Jay P. Kesan, College of Law, University of Illinois

International IP Protection for Plants Dr. Humphrey Foote, Senior Associate, AJ Park

Regulatory Issues in Protection of Plant Products, GMOS, Diagnostics Dr. Thomas E. Nickson, International Policy Lead, Monsanto

Public Policy and Education Issues Sarah Hull, Head, Syngenta External Affairs

Please join us in Washington in October for this excellent, educational program!  The session will begin at about 3:40 PM in the Wardman Park Marriott Hotel.


USPTO Relations Subcommittee

Report from BCP Customer Partnership Meeting – 9 September 2013

Suzannah K. Sundby, Smith, Gambrell & Russell, LLP

Copies of the handouts from this meeting and from prior meeting can be obtained at

Wanda Walker and Jerry Lorengo opened the meeting.


Kathleen Bragdon (TC1600) and Gerald Leffers (OPQA) , gave a phenomenal presentation on the training being provided to examiners on AIA FITF office actions and art rejections (and exceptions).  The training/workshop materials are available from the USPTO website at  Many who participated in person said that they are going to implement similar worksheets in their case files and use for client counseling.  These are the same materials that were discussed at the Second Anniversary AIA Forum that was held on 16 September 2013.  For more information go to

Enhancing Efficiency Training and 102/103 Rejections

Jean Witz (QAS, TC1600) and Ashwin Mehta (QAS, TC1600) gave a presentation on enhancing efficiency training relating to 102 and 103 rejections focusing on inherency (including inherency as applied to obviousness), range limitations, and routine optimization.  They discussed case law and its application to specific facts.  The slide set provides a great overview of applicable case law.

Jean Witz then covered examiner training materials that are designed to help examiners provide better rejections.  This portion was also a workshop format where attendees, acting as a supervising examiner, reviewed a claim set, specification, prior art materials, and a junior examiner’s rejections, and then commented on the rejections (e.g., correctness, applicability, analysis, etc.).

Track I Analysis

Kate Gaudry of Kilpatrick Townsend gave a presentation which covered a statistical analysis of Track 1 applications including their allowance rates, speed of prosecution, and cost as compared to regular applications.

The meeting concluded and many of us continued our lively discussions at the Trademark Bar.

Next Meeting – 10 December 2013

The next BCP meeting will be held 10 December 2013.  This meeting will be a special BCP meeting as Acting Director Teresa Rea will be attending. 

If there are any issues or topics that you wish to hear, please let the biotechnology committee know about them or send your ideas to Cecilia Tsang (571-272-0562 or or to the Group Directors.

Happy Hour

For those wanting more mix and mingle opportunities, come join us for Happy Hour after each BCP meeting at the Trademark Bar for   and lively discussions having little to do with patent law.


Committee Annual Survey

We would like your input about the committee.  If you care to, please go to and provide your answers to one or more of the five questions on the survey.  The five questions are:

1. How can the leadership of AIPLA’s Biotechnology Committee better meet your expectations?

2. What issues or subcommittee(s) would you like to be involved in? (Options are: Diagnostic and Gene Patenting, Biosimilars, Tech Transfer and Licensing, Plant Biotech, Litigation, PTAB Proceedings, and Industrial Biotech)

3. Other / comments to clarify your answers.

4. How can the leadership of AIPLA’s Biotechnology Committee better communicate developments of interest to you?

5. Other / comments to clarify your answers, for example, frequency (e.g., monthly /weekly/daily/newsflash); content (detailed analyses/short summaries); and/or format (Biotech Buzz/emailed or posted weekly newsletter/daily blog or linked-i


Join the Committee on LinkedIn!

The Biotech committee is now a sub-group on Linked-In.  We can use this social networking group to better keep in touch with each other.  For example, the linked in page will allow you to send messages to each other or engage in group discussions and informal polls without clogging the inboxes of people who do not wish to participate. 

Also, for those of you who are interested in getting more involved, the Linked-In group will be used by subcommittee chairs to call for volunteers on projects and to announce events, such as CLE webinars or interesting news items.

Of course, participation is voluntary.  If interested in joining, please follow the directions below.

Step 1.  If you are not a member of Linked-In, please join.  It’s free.  Just click on the following link and follow the directions:

Step 2. Once you have joined, go to the search spot at top (look for the magnifying glass).

Step 3.  Search “American Intellectual Property Law Association” and request to join.

Step 4.  Go back to the Search bar, search for “AIPLA FDA Committee”, and request to join.  You can restrict by “group” using the drop down menu just to the left of the search bar.  Also, joining the main AIPLA group is required because you have to join the main group to join any subgroup, such as the Biotech committee.  For each request to join, it should say that your approval is pending.  The AIPLA IT staff will check that you are actually a member, and if so, approve you.

Step 5.  Start posting.

If you have any questions, please contact William Childs at


AIPLA Spring Meeting, Seattle, Washington, May 1-3, 2013

May 2, 3:30 – 5:30, Biotechnology IP Practice in Latin America (120 Minutes of CLE)

The Biotechnology Committee and the IP Practice in Latin America Committee are collaborating to present 2 hours of CLE on some of the latest and most important issues affecting patent practitioners who procure and maintain patent protection on biotechnology related inventions in Latin America. The topics to be addressed will cover (1) status of plant variety patent protection; (2) biological pharmaceuticals and biosimilars; (3) whether protection is available for diagnostics and gene patenting; and (4) any specific peculiarities in each country in obtaining and maintaining patent protection (i.e., compulsory licensing issues). The speakers will be:

Ignacio Manuel Sanchez Echagüe, Marval O’Farrell & Mairal, Buenos Aires, Argentina

Leonor Galvão de Botton, Murta Goyanes, Rio de Janeiro, Brazil

Luis Diego Castro, Castro & Pal Asociados, San José, Costa Rica

Eugenio Pérez, Uhthoff, Gómez Vega & Uhthoff, Mexico City, Mexico

May 2, 3:30 – 5:30, “Reverse Payments” – Food and Drug, Antitrust, ADR Joint Session

Biotech members may want to be aware of a session that conflicts with our joint CLE session with IP Practice in Latin America (see above).  The Food and Drug, Antitrust, and Alternate Dispute Resolution committees have planned a panel on so-called “reverse payment” settlements in ANDA litigations, which is the topic of the FTC v. Actavis case before the US Supreme Court this term.  The anticipated panel includes Steve Shadowen of Hilliard & Shadowen LLC, Guy Donatiello of Endo Pharmaceuticals Inc., an economics professor offering an economic perspective, and a representative of the ADR committee.  Look for additional details on this topical panel in April issue of the Biotech Buzz.

AIPLA Trip to Mexico City—June 5-7, 2013

AIPLA members, including AIPLA’s Executive Director, Todd Dickinson, AIPLA’s current President, Jeffrey Lewis and at least one of the AIPLA’s Board Members, Mike Martinez, will be visiting Mexico City June 5th-7th in 2013.  Biotech committee members would be welcome to attend.  If you wish to be part of AIPLA’s delegation, go to to book your room directly over the Internet.  The normal rate is $399.99 plus tax, per night.  However, we were able to obtain a group preferred rate of $237.00 plus tax, per night.  The Group Code to use over the Internet is AIPAIPA.  If you book your rooms over the phone, then the Group Code is simply AIPLA.  If you are attending, book your room immediately and then please let James Larson know.

AIPLA Mid-Winter Institute, Tampa, Florida, February 2013

The Biotech Committee partnered with the Chemical Practice Committee to plan 3 hours of CLE in two panels for Thursday afternoon during the MWI in Tampa, Florida.

Obtaining Value from IP in Personalized Medicine

Lawyers from a very diverse spectrum of entities involved in personalized medicine and diagnostics provided views about the value of IP for the development of new products and services.  

Judith Roesler of the Roesler Law Offices, PLLC moderated the panel, which consisted of:

Manny Vacchiano, Lead Patent Attorney (PCR and Medical Sciences business units), Life Technologies;

Yuko Soneoka, Senior Corporate Counsel IP, Genome Health, Inc.;

Robert L. Sharp from Eli Lilly and Company;

Natalie Wright Curley, Managing Director of the Office of Technology Commercialization, MD Anderson Cancer Center; and

Jarett Rieger, Director and Associate General Counsel of the Office of Technology Mgmt & Commercialization, Moffitt Cancer Center and Research Institute in Tampa, FL.  

About 90 people attended this session.  Manny’s slides, Yuko’s slides, Robert’s slides, Natalie’s slides, and Jarrett’s slides are available.

To meet one of its objectives, our Diagnostics and Gene Patenting Subcommittee created a white paper titled “IP Value for Personalized Medicine” with contributions from Judy Roesler, Ling Zhang, Lynn Tyler, and Karen Canady.  This paper was provided to attendees to fulfill CLE requirements.

Mark Stewart and Robert Sharp of Eli Lilly and Company provided another paper titled “IP Considerations Associated with Companion Diagnostic Discovery and Development.” 

Aligning IP Strategies with Business Objectives Up and Down the Supply Chain

Lead intellectual property counsel from several large companies provided their views about the value of intellectual property in each of their businesses and how they work with suppliers and customers to modify their IP and licensing strategies depending on their place along the supply chain.  The panelists were:

Richard Phillips, Chief Attorney Technology, ExxonMobil Chemical;

Patrick Bengtsson, VP, Assoc. GC, IP, The Clorox Company;

Valerie L. Calloway, Chief IP Counsel, Polymer Group, Inc.; and

Nancy M. Klembus, Assistant General Counsel, Kimberly-Clark, Corp.

Carol Nielsen of Nielsen IP Law, Houston TX moderated the panel.  The panelists addressed questions, such as: How does a company’s position in a supply chain affect IP strategies?  How do companies that are suppliers and customers adjust their approaches to IP acquisition and licensing in light of business relationships?  How do companies use IP to obtain value in the marketplace even when their businesses might not be thought of as innovative?  The session was also well-attended and a dynamic interchange with the audience occurred.

Case Law Reports

Case Law Report Link

Cancer Voices of Australia v. Myriad Genetics, reported byTrevor J. Davies, PhD, Allens Patent & Trade Mark Attorneys, Sydney, Australia.

[2013] FCA 65 (15 February 2013) (confirming patentability of isolated genetic material under Australian law). 

Abbott GmbH & Co., KG v. Centocor Ortho Biotech, Inc., reported byLynn C. Tyler and Michael R. Brunelle, Barnes & Thornburg LLP, Indianapolis, Indiana, USA.

No. 09-11340-FDS (D. Mass. 2012) (update on high profile patent infringement case related to patentability requirements for antibody inventions). 

Verinata Health, Inc. and The Board of Trustees of the Leland Stanford Junior University v. Sequenom, Inc, reported byWilliam R. Schmidt, Wenderoth, Lind & Ponack LLP, Washington, D.C. , USA.

No. 4:12-cv-00865-SI (N.D. Cal. 2012) (developing case on patentable subject matter for diagnostic inventions). 


USPTO Subcommittee

Report from the Joint Medical Device—Biotechnology & Chemical Partnership Meeting – January 29

Contributed by Julie Broadus Meigs, Ph.D., Womble Carlyle Sandridge & Rice, LLP, Tysons Corner, VA.

This was the second meeting co-sponsored by USPTO Technology Centers 1600 and 3700.  The combined forum is intended to facilitate discussion between practitioners and the USPTO on similar issues facing both technology practice areas.  Copies of the handouts from this meeting and from prior meetings can be obtained at

Teresa Stanek Rea (Deputy Under Secretary of Commerce for Intellectual Property and Deputy Director of the USPTO) gave a brief introduction and welcome.

There was an announcement made regarding a joint partnership between the USPTO and the Smithsonian Institution to stage a 2013 Innovation Expo.  The Expo will serve as a template for the Innovation Pavilion to be presented at the Smithsonian’s Arts and Industries Building upon its reopening in summer 2014.  Patentees interested to showcase their technology at the Expo must apply by 31 March 2013.  For more information and link to the application form see

CPC – Cooperative Patent Classification

By Don Hajec (Director TC 3700) and Derris Banks (Director TC 2600)

The presenters gave an overview of the just-launched CPC prior art collection that will ultimately replace the current United States Patent Classification (USPC) system by 2014.  The CPC is a bilateral USPTO/EPO initiative to promote work sharing between patent offices as well as the public.  The new classification system is based upon the International Patent Classification (IPC) standards, but it is designed to be more adaptive and actively maintained.  The presenters explained CPC nomenclature and provided examples of search strategies.  A tentative schedule of upcoming external training opportunities and links to additional resources are included at the end of the presentation materials.

Evaluating Subject Matter Eligibility Under 35 USC § 101

By Marjorie Moran (Supervisory Patent Examiner, AU 1631)

Ms. Moran talked through examination guidelines for patent subject matter eligibility.  The guidelines are included in MPEP 2104, 2105, and 2106 (Ed. 8, Rev. 9, 2012).  The presentation primarily focused on the judicial exceptions to subject matter eligibility:  laws of nature, natural phenomena, and abstract ideas, guided by Mayo v. Prometheus (Sup. Ct. 2012).  Two examples were analyzed – the first pertaining to claims for treating a disorder, and a second pertaining to claims for methods of determining disease risk.  Additional examples are currently being developed and will be published for examiner training and practitioner use. 

America Invents Act (AIA) Update Including First-Inventor-To-File

By Janet Gongola (Associate Commissioner for Patent Examination Policy, Patent Reform Coordinator); Presented by Mary Till (Legal Advisor, Office of Patent Legal Administration)

Ms. Till provided an overview of AIA provisions that will become effective next month, including provisions for first-inventor-to-file, fee setting, and micro entity status.  She stated that comments submitted in response to the USPTO proposed examination guidelines for implementing the first-inventor-to-file provisions (published in July 2012) had been considered.  The final rules and examination guidelines have since published.  See 78 FR 11023-11059 (February 14, 2013) and 78 FR 11059-11088 (February 14, 2013).  The AIA Technical Corrections Legislation was also briefly discussed.  Resources are available for assistance with complying with changes under the AIA, including dedicated staff that may be contacted by phone or email (see end of presentation for contact information).

Open Round Table Discussion

Panelists:  Don Hajec (Director, TC 3700), Jerry Lorengo (Director, TC 1600), Angela Sykes (Director, TC 3700); Mary Till (Legal Advisor, Office of Patent Legal Administration); Wanda Walker (Director, TC 1600); Andrew Wang (Director, TC 3700)

The Round Table Discussion included a lively discussion of various topics, including first action interviews, the RCE backlog and delay in consideration, additional questions about the subject matter eligibility guidelines, efforts to improve communication between examiners and practitioners, compact prosecution goals, and the AIA rule changes regarding third party submissions.

Next Meeting – June 5

The next scheduled meeting will be Tuesday, 5 June 2013.  Please refer to  for the schedule announcement and agenda. 

If there are any issues or topics that you wish to hear, please share your ideas with the Customer Partnership Team: Bennett Celsa (QAS TC 1600); Sue Lie (SPE AU 1616); Karlheinz Skowronek (SPE AU 1654); Cecilia Tsang (571-272-0562 or; Brian Casler (SPE TC 3700); Linda Dvorak (SPE AU 3739); Tom Hughes (SPE 3731); Kevin Sirmons (SPE AU 3767); or to


If you have any questions regarding the content of this summary, or would like further details of the live discussion, you are welcome to email the Biotech Committee/USPTO Relations Subcommittee co-chairs, Julie Meigs and Suzannah Sundby.

NEW! Regional Subcommittees

The Biotech Committee is organizing regional subcommittees that will host events throughout the United States (and abroad).  The first regional subcommittee to be formed is the Maryland/DC/Virginia Events Subcommittee.  Keep an eye out for additional regional subcommittees forming in your area, or volunteer to organize a regional subcommittee by emailing Jim Kelley (

MD/DC/VA Events Subcommittee

For its first event, the AIPLA Biotechnology Committee MD/DC/VA Events group met for food and drink at an exquisite restaurant in Rockville, Maryland, about ten miles from Washington, DC.   The restaurant is styled after the great camps of the Adirondack Mountains that were constructed in the latter half of the nineteenth century.  The event lasted about two hours, and lively conversation allowed members to get to know one another; a good time was had by all.  The AIPLA Biotechnology Committee MD/DC/VA Events group encourages committee members in the greater Washington, DC metropolitan area to join the group by visiting look forward to seeing you at our next event.

International Issues

Brazil Issues Permit for Production of Follow-On Biologics

Contributed by Benny Spiewak, Zancaner Costa, Bastos e Spiewak Advogados, São Paolo, Brazil

On February 18, 2013 the Brazilian Official Gazette announced that the Brazilian company Bionovis obtained a manufacturing permit authorizing the construction of a site focused on the development of biologic drugs, mainly a follow-on biologic version of the rheumatoid arthritis therapy ETANERCEPT.  The announcement marks the initial milestone of a project that aims at creating a strong, highly competitive biopharmaceutical market in Brazil.  Bionovis is a joint-venture forged by the Brazilian Government and four (4) of the biggest Brazilian pharmaceutical players, i.e., Aché, EMS, Hypermarcas and União Química.

For the purposes of developing the follow-on version of the drug, Bionovis entered into a PDP, i.e., Partnership for Productive Development, with two (2) Brazilian public pharmaceutical and research laboratories, Vital Brazil Institute and Farmanguinhos.  The terms of the PDP are not publicly known, but Bionovis announced it contains technology transfer provisions, as well as plans to invest over US$15mi in clinical trials and development efforts.  Several PDPs are being forged by the Government that aims at creating extremely competitive and efficient Brazilian biopharmaceutical players.

Currently, the reference product to be followed-up by Bionovis is manufactured by Boehringer Ingelheim Pharma KG and is both imported into and commercialized within the Brazilian territory by Wyeth-Whitehall.  The Brazilian Unified System of Health plans to save fifty (50%) of the budget dedicated procurements of the drug in five (5) years, reaching savings of approximately US$ 300 mi.

The Brazilian follow-on biologics-related regulation is fairly recent, i.e., December 2010, and is yet to be stress tested. ANVISA, the Brazilian Regulatory Agency’s Ruling no. 55/10 created a combined, yet unclear pathway for the approval of biosimilar products. While new biologic products are to be presented and assessed from a classical full dossier approach, the so-called biologic products (i.e., ANVISA still refrains from using the international terminology for follow-on biologics) are to observe either one of the two existent systems, the biosimilar, comparative pathway or the individual, standalone pathway.

It is relevant to highlight the opinion of ANVISA on the existence of the presence at RDC 315/10 of the dual regulatory system: “while we have proposed the individual development pathway this should not be the first pathway of choice for a biotherapeutic product.” The new regulatory pathway covering new biologics and biologic products will surely push to an explosive growing of the market figures, as well as the regulatory and legal challenges associated therewith.

On a side note, please be informed that ANVISA announced its intention to issue two (2) new pieces of regulation covering and updating respectively the regulatory pathway of synthetic and semi synthetic active pharmaceutical ingredients and the Good Manufacturing Practices.